A randomized controlled trial is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments.
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.
In published academic research, publication bias occurs when the outcome of an experiment or research study biases the decision to publish or otherwise distribute it. Publishing only results that show a significant finding disturbs the balance of findings in favor of positive results. The study of publication bias is an important topic in metascience.
Ben Michael Goldacre is a British physician, academic and science writer. He is the first Bennett Professor of Evidence-Based Medicine and director of the Bennett Institute for Applied Data Science at the University of Oxford. He is a founder of the AllTrials campaign and OpenTrials to require open science practices in clinical trials.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Medical research, also known as experimental medicine, encompasses a wide array of research, extending from "basic research", – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine.
PLOS Medicine is a peer-reviewed weekly medical journal covering the full spectrum of the medical sciences. It began operation on October 19, 2004, as the second journal of the Public Library of Science (PLOS), a non-profit open access publisher. All content in PLOS Medicine is published under the Creative Commons "by-attribution" license. To fund the journal, the publication's business model requires in most cases that authors pay publication fees. The journal was published online and in a printed format until 2005 and is now only published online. The journal's acting chief editor is Clare Stone, who replaced the previous chief editor, Larry Peiperl, in 2018.
In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases. Case reports are professional narratives that provide feedback on clinical practice guidelines and offer a framework for early signals of effectiveness, adverse events, and cost. They can be shared for medical, scientific, or educational purposes.
David Frederick Horrobin was a British-Canadian entrepreneur, medical researcher, author and editor. He is best known as the founder of the biotechnology company Scotia Holdings and as a promoter of evening primrose oil as a medical treatment, Horrobin was founder and editor of the journals Medical Hypotheses and Prostaglandins, Leukotrienes and Essential Fatty Acids, the latter journal co-founded with his then graduate student Morris Karmazyn.
In epidemiology, reporting bias is defined as "selective revealing or suppression of information" by subjects. In artificial intelligence research, the term reporting bias is used to refer to people's tendency to under-report all the information available.
Nancy Fern Olivieri is a prominent Toronto haematologist and researcher with an interest in the treatment of haemoglobinopathies. She is best known for a protracted struggle with the Hospital for Sick Children and the pharmaceutical company Apotex about the drug deferiprone.
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is an illness with a long history of controversy. Some professionals within the medical community do not recognize ME/CFS as a genuine condition, nor is there agreement on its prevalence. There has been much disagreement over the pathophysiology of chronic fatigue syndrome, how it should be diagnosed, and how to treat it.
Left atrial enlargement (LAE) or left atrial dilation refers to enlargement of the left atrium (LA) of the heart, and is a form of cardiomegaly.
Funding bias, also known as sponsorship bias, funding outcome bias, funding publication bias, and funding effect, refers to the tendency of a scientific study to support the interests of the study's financial sponsor. This phenomenon is recognized sufficiently that researchers undertake studies to examine bias in past published studies. Funding bias has been associated, in particular, with research into chemical toxicity, tobacco, and pharmaceutical drugs. It is an instance of experimenter's bias.
Malcolm VandenBurg is a British doctor involved in drug research, sexual health, medicolegal advice and stress management.
George Lewith was a professor at the University of Southampton researching alternative medicine and a practitioner of complementary medicine. He was a prominent and sometimes controversial advocate of complementary medicine in the UK.
AllTrials is a project advocating that clinical research adopt the principles of open research. The project summarizes itself as "All trials registered, all results reported": that is, all clinical trials should be listed in a clinical trials registry, and their results should always be shared as open data.
Study 329 was a clinical trial which was conducted in North America from 1994 to 1998 to study the efficacy of paroxetine, an SSRI anti-depressant, in treating 12- to 18-year-olds diagnosed with major depressive disorder. Led by Martin Keller, then professor of psychiatry at Brown University, and funded by the British pharmaceutical company SmithKline Beecham—known since 2000 as GlaxoSmithKline (GSK)—the study compared paroxetine with imipramine, a tricyclic antidepressant, and placebo. SmithKline Beecham had released paroxetine in 1991, marketing it as Paxil in North America and Seroxat in the UK. The drug attracted sales of $11.7 billion in the United States alone from 1997 to 2006, including $2.12 billion in 2002, the year before it lost its patent.
Joseph Gavin Collier is a British retired clinical pharmacologist and emeritus professor of medicines policy at St George's Hospital and Medical School in London, whose early research included establishing the effect of aspirin on human prostaglandins and looking at the role of nitric oxide and angiotensin converting enzyme in controlling blood vessel tone and blood pressure. Later, in his national policy work, he helped change the way drugs are priced and bought by the NHS, and ensured that members of governmental advisory committees published their conflicts of interest.
Conflicts of interest (COIs) often arise in academic publishing. Such conflicts may cause wrongdoing and make it more likely. Ethical standards in academic publishing exist to avoid and deal with conflicts of interest, and the field continues to develop new standards. Standards vary between journals and are unevenly applied. According to the International Committee of Medical Journal Editors, "[a]uthors have a responsibility to evaluate the integrity, history, practices and reputation of the journals to which they submit manuscripts".
